AccessGUDID - DEVICE: Bradshaw Medical (00810019931529)

GUDID

Device Identifier (DI) Information

Brand Name: Bradshaw Medical
Version or Model: HRC212312
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HRC601
Company Name: Bradshaw Medical, Inc.

Primary DI Number: 00810019931529
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 621830582 *Terms of Use

Device Description: Handheld Ratcheting Rod Cutter,3.2mm, 3.5mm Silpad Black Sold as OEM

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?
44800	Internal spinal fixation system cable cutter	A scissors-like, heavy-duty, hand-held surgical instrument specifically designed to cut steel cables used as part of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The device is typically designed to cut the cable in situ. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXZ	Cutter, Wire

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: 2d2458e2-356a-40ff-bef5-558b6b5bb321
Public Version Date: November 08, 2023
Public Version Number: 2
DI Record Publish Date: January 13, 2022

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: 12629251374
Email: CustomerService.KEN@intech-medical.com

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