AccessGUDID - DEVICE: Gen2 (G277G2N113690)

GUDID

Device Identifier (DI) Information

Brand Name: Gen2
Version or Model: G2N11369
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G2N11369
Company Name: SURGIX MEDICAL LLC

Primary DI Number: G277G2N113690
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080402644 *Terms of Use

Device Description: CRILE GASSERIAN GANGLION KNIFE/DISSECTOR 8.5"

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?
35135	Dura mater knife	A hand-held manual surgical instrument designed to cut or incise the dura mater without damaging the underlying structures during a surgical intervention. It is typically a one-piece instrument with a sharp, single-edged, cutting blade terminating in a hook shape at the distal end (the internal radius of the hook has the cutting edge) which is normally very small; it has a long slender shaft with a handle at the proximal end. It is normally made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAO	Instrument, Surgical, Non-Powered

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
Length: 8.5 Inch

Device Record Status

Public Device Record Key: 882d1415-34f6-486e-8eb8-029fbc5417cd
Public Version Date: October 05, 2022
Public Version Number: 1
DI Record Publish Date: September 27, 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: 888-247-0477
Email: customerservice@surgixmedical.com

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

FDA TOOLS & RESOURCES