AccessGUDID - DEVICE: Symmetry Surgical (00887482126660)

GUDID

Device Identifier (DI) Information

Brand Name: Symmetry Surgical
Version or Model: 78-3015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 78-3015
Company Name: SYMMETRY SURGICAL INC.

Primary DI Number: 00887482126660
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079641356 *Terms of Use

Device Description: Symmetry® Passer, Tendon, Curved, Pointed Tip, Adult, 6 in

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?
62667	Laparoscopic tissue manipulation forceps/working-channel	A rigid, hand-held manual surgical instrument designed to be introduced through a laparoscope/laparoscopic port for: 1) atraumatic grasping/clamping of soft tissues (e.g., gallbladder); and 2) access adjacent to the site of clamping (e.g., during laparoscopic cholangiography). It is a hand-held device with proximal handles, a rigid long slender shaft with a built-in working-channel, and distal grasping blades. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWQ	Passer

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: 6 Inch

Device Record Status

Public Device Record Key: d7e01fa5-56ad-4683-be9a-6bd89f673f95
Public Version Date: May 23, 2025
Public Version Number: 4
DI Record Publish Date: August 20, 2024

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: Yes
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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1 888-364-7004
Email: customerservice@symmetrysurgical.com

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