AccessGUDID - DEVICE: Jacobson Combination Spoon (G20224080521412)

GUDID

Device Identifier (DI) Information

Brand Name: Jacobson Combination Spoon
Version or Model: 240805214
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 24-08052-14
Company Name: CONCISE ENTERPRISES

Primary DI Number: G20224080521412
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 645816062 *Terms of Use

Device Description: The Jacobson Combination Spoon is a medical instrument that is designed for use in curettages, excochleations, and dentistry procedures. This hygienic surgical instrument is individually sterile-packaged and clearly marked as a disposable instrument by the double labeling, ensuring that it is safe and suitable for single-use. The hand instrument features a unique design that combines a smaller and a larger sharp spoon in both versions, making it versatile and ideal for a range of medical applications. It is typically made of high-quality stainless steel, which is durable and easy to clean. Overall, the Jacobson Combination Spoon is an important tool for healthcare professionals who perform procedures such as curettages, excochleations, and dentistry. Its design and construction are intended to ensure optimal functionality, safety, and hygiene in these medical contexts.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
31335	Bone curette, reusable	A manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTF	Curette

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 694d7fcf-dc66-428d-bbc2-21399afcdc44
Public Version Date: April 17, 2023
Public Version Number: 1
DI Record Publish Date: April 07, 2023