AccessGUDID - DEVICE: BLAKESLEY THRU CUT FORCEPS (00192896057807)

GUDID

Device Identifier (DI) Information

Brand Name: BLAKESLEY THRU CUT FORCEPS
Version or Model: 1272-506IN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1272-506IN
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896057807
Issuing Agency: GS1
Commercial Distribution End Date: October 15, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: BLAKESLEY THRU CUT FORCEPS QUICK CLICK INSERT

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?
32853	Orthopaedic joint/limb rongeur	A hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTD	FORCEPS

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
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 3.6 Millimeter Tip
Device Size Text, specify: 45 Degree Tip
Length: 5 Inch

Device Record Status

Public Device Record Key: 5cba4cb1-3dfa-4e27-b02e-80661499cc49
Public Version Date: October 16, 2020
Public Version Number: 3
DI Record Publish Date: September 10, 2018