DEVICE: Surtex (05055445977313)

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Device Record History
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Device Identifier (DI) Information
Surtex
TL-367-08
In Commercial Distribution

SURTEX INSTRUMENTS LTD.
05055445977313
GS1

1
216232502 *Terms of Use
Micro Laryngeal Cup Biopsy Forcep Ø 3.0 mm Curved Left 35 cm - 13 3/4" Stainless Steel
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Device Characteristics
MR Conditional
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
11775 Open-surgery biopsy forceps, reusable
A hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FCL FORCEPS, BIOPSY, NON-ELECTRIC
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
08b8ed99-1682-4992-b8b9-da91e4b1fccb
May 20, 2026
1
May 12, 2026
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
+442081233513
qa@surtex-instruments.co.uk
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