AccessGUDID - DEVICE: N/A (00840329810504)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: B67241
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B67241
Company Name: BLACK & BLACK SURGICAL, INC.

Primary DI Number: 00840329810504
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004382282 *Terms of Use

Device Description: GUYURON NASAL TIP CARTILAGE PUNCH, FIGURE-EIGHT SHAPE W/HANDLE, 4"

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?
37840	Cartilage knife	A hand-held manual surgical instrument designed for cutting, shaving or shaping cartilage during a surgical intervention. It is typically a one-piece instrument with a sharp, single-edged, cutting blade at the distal end which is normally very long, similar in shape to a scalpel blade, and may vary in length and size; it has a handle at the proximal end. It is normally made of high-grade stainless steel. Also known as a chondrotome, a cartilage knife can also be used in pathology procedures. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMF	KNIFE, SURGICAL

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: 288cfaf4-2854-4121-93dd-4609b8ea826b
Public Version Date: September 29, 2022
Public Version Number: 1
DI Record Publish Date: September 21, 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: +1(770)414-4880
Email: info@blackandblacksurgical.com

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