AccessGUDID - DEVICE: Bradshaw Medical Inc. (00810019930584)

GUDID

Device Identifier (DI) Information

Brand Name: Bradshaw Medical Inc.
Version or Model: RG-000610DG-ATEC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RG-000601DG-ATEC
Company Name: Bradshaw Medical, Inc.

Primary DI Number: 00810019930584
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 621830582 *Terms of Use

Device Description: R-GRP, LUMBAR SLIMLINE

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):	Yes
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?
38622	Surgical vice grip	A heavy-duty, hand-held, surgical instrument with specially designed sturdy handles and gripping jaws intended to be used to securely grip around or hold an object during a surgical intervention. It is made of high-grade stainless steel and is designed like an adjustable wrench and has handles that are self-locking when squeezed closed. The jaws are strong, typically having a concave grip with heavy serrations, and are pivoted with an adjustable ratio-lever exchange to achieve the optimum gripping aperture and gripping force. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

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: 4d5a7190-bdb8-4c97-847e-9af197905731
Public Version Date: November 08, 2023
Public Version Number: 2
DI Record Publish Date: April 30, 2021