AccessGUDID - DEVICE: Teale Tenaculum, Slight Curve (GYNX35360)

GUDID

Device Identifier (DI) Information

Brand Name: Teale Tenaculum, Slight Curve
Version or Model: 3536
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GYNEX CORPORATION

Primary DI Number: GYNX35360
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012997685 *Terms of Use

Device Description: No description.

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):	No
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?
32598	Uterine fibroid hook	A shaft-like surgical instrument whose distal end tapers to form a hook or multiple hooks used to fix or apply traction to uterine fibroids during a gynaecological procedure. It is typically a one-piece instrument made of high-grade stainless steel with a handle at the proximal end that is available in various shapes. In multiple hook designs, the hooks are in parallel. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HDC	Tenaculum, Uterine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K980247	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: bdf68372-80af-4db9-98d4-edaa1c57b129
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 10, 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

[?]

No Customer Contact currently defined

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