FDA.report

Strauss Surgical

Primary DI
00851925007885
Brand
Strauss Surgical
Company
AMERICAN MEDICAL ENDOSCOPY, INC.
Model
STS-LAP-305-10
Published
2023-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HETLaparoscope, Gynecologic (And Accessories)

Product Code Classifications

CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00851925007885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00851925007885008519250078858519250078850851925007885

GMDN Terms

TermDefinition
Endoscopic electrosurgical electrode, bipolar, reusableAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles). 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
false
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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06972304750414DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
16972304750381DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
16972304750398DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
16972304750428DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
16972304750435DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
04251303822769BLUEENDOTROKAMED GmbHHET2026-03-03
04251303824961BLUEENDOTROKAMED GmbHHET2026-02-27
04251303824978BLUEENDOTROKAMED GmbHHET2026-02-27
00817401029130EndoplusEndoplusHET2026-02-06
00817401029123EndoplusEndoplusHET2026-01-16
00817401029116EndoplusEndoplusHET2025-12-19
00198506086892ELMED INCORPORATEDELMED INCORPORATEDHET2025-11-25
G465FG16000Non-ICG 5mm Laparoscope (0 Deg)Smartsurgn Inc.HET2025-08-27
G465FG17000Non-ICG 5mm Laparoscope (30 Deg)Smartsurgn Inc.HET2025-08-27
00198506044229ELMED INCORPORATEDELMED INCORPORATEDHET2025-08-15
00198506084256ELMED INCORPORATEDELMED INCORPORATEDHET2025-07-24
04048223128121Cutting introducer cannula for Veress-Pajunk GmbH MedizintechnologieHET2025-06-17
04048223128145Cutting introducer cannula for Veress-Pajunk GmbH MedizintechnologieHET2025-06-17
EAMIICT50100i-Cut Power SupplyAMI Agency for Medical Innovations GmbHHET2025-05-05
EAMIICT50110i-CutAMI Agency for Medical Innovations GmbHHET2025-05-05
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00198506082542ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-30
00198506026096ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-15
00198506026119ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-15
00198506027215ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-15
00198506027222ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-15
00817401029109EndoplusEndoplusHET2025-04-10
00198506081330ELMED INCORPORATEDELMED INCORPORATEDHET2025-03-17
00817401029093EndoplusEndoplusHET2025-03-14