AccessGUDID - DEVICE: BREMER (10705034000022)

GUDID

Device Identifier (DI) Information

Brand Name: BREMER
Version or Model: 1365
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1365
Company Name: DEPUY SPINE, LLC

Primary DI Number: 10705034000022
Issuing Agency: GS1
Commercial Distribution End Date: March 08, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 107105876 *Terms of Use

Device Description: BREMER HALO SYSTEM TONG PIN SET

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
46524	Surgical traction skull tongs	An instrument used during orthopaedic surgery to perform traction on the cervical spine by applying an upward force to the skull that causes hyperextension of the head and neck. It is typically a two-arm pivoted instrument that is attached to the skull using pins (either partially implanted or not); the proximal end includes a mechanism (e.g., an adjustable threaded bolt and nut) responsible for the application of the traction force. This device is typically used during procedures to treat a fractured spine. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAX	TONG, SKULL FOR TRACTION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K954069	000

Device Exempt from Premarket Submission: No 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: d0a2b5be-9979-4634-b9e0-5aebfadda71a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 30, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)255-2500
Email: xx@xx.xx

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES