FDA.report

Strauss Surgical

Primary DI
00850024135291
Brand
Strauss Surgical
Company
AMERICAN MEDICAL ENDOSCOPY, INC.
Model
STS-LAP-020-54
Published
2020-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FHQHolder, Needle, Gastroenterologic

Product Code Classifications

CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850024135291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850024135291008500241352918500241352910850024135291

GMDN Terms

TermDefinition
Needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
024725124
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810143892963Strauss SurgicalSTS-HYS-GRA-50-40AS2025-06-05
00810143891294Strauss SurgicalSTS-NEP-420-25QL2025-04-25
00810143891300Strauss SurgicalSTS-URO-30-70-B102025-04-25
00810143891317Strauss SurgicalSTS-URO-HANDLE2025-04-25
00810143891324Strauss SurgicalSTS-NEP-420-142025-04-25
00810143891331Strauss SurgicalSTS-NEP-420-14T2025-04-25
00810143891348Strauss SurgicalSTS-NEP-420-162025-04-25
00810143891355Strauss SurgicalSTS-NEP-420-192025-04-25
00810143891362Strauss SurgicalSTS-NEP-521-2502025-04-25
00810143891379Strauss SurgicalSTS-NEP-526-2502025-04-25
00810143891386Strauss SurgicalSTS-NEP-521-2002025-04-25
00810143891393Strauss SurgicalSTS-NEP-526-2002025-04-25
00810143891409Strauss SurgicalSTS-NEP-500-092025-04-25
00810143892871Strauss SurgicalSTS-URO-SCI-70-40BLF2025-04-09
00810143892888Strauss SurgicalSTS-HYS-GRA-50-40CAS2025-04-09
00810143892895Strauss SurgicalSTS-URS-GRA-50-60CAR2025-04-09
00810143892901Strauss SurgicalSTS-URS-GRA-50-60PR2025-04-09
00851925007960Strauss SurgicalSTS-LAS-940-SBS2025-01-22
00810143892550Strauss SurgicalSTS-URS-GRA-40-60PS2024-12-03
00810143892567Strauss SurgicalSTS-URS-GRA-40-60SR2024-12-03

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00848657076029AED 6252 Mathieu Handle Laparoscopic Needle Holder, 33cm, Curved Right JawNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FHQ2026-01-15
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D9283011600NEEDLE HOLDER RYDER 5 1/8" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011640NEEDLE HOLDER FRENCH RYDER 9" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011650NEEDLE HOLDER HEANEY 8 1/4" - 20CMW.H. Holden, Inc.FHQ2026-01-05
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