FDA.reportPublic FDA data

Single-Use Alligator Grasper

Primary DI
06975339628628
Brand
Single-Use Alligator Grasper
Company
MacroLux Medical Technology Co., Ltd.
Model
GF-S-1.6×380-O
Device description
Single-Use Alligator Grasper, GF-S-1.6×380-O
Published
2026-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HFBForceps, Biopsy, Gynecological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFBForceps, Biopsy, GynecologicalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16975339628625PackageGS110In Commercial Distribution
26975339628622PackageGS110In Commercial Distribution
06975339628628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697533962862516975339628625
2697533962862226975339628622
06975339628628069753396286286975339628628

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic tissue manipulation forceps, single-useA rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.

Regulatory Flags#

DUNS number
723490133
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975339623418SeleneView®HO422026-07-03
06975339628406Single-Use Biopsy ForcepsBF-S-1.6×3802026-07-03
06975339628413Single-Use Alligator GrasperGF-S-1.6×3802026-07-03
06975339628420Single-use Endoscopic ScissorsPS-S-1.6×3802026-07-03
06975339628512Single-Use Biopsy ForcepsBF-F-1.8×6002026-07-03
06975339628529Single-Use Biopsy ForcepsBF-F-1.8×600-G2026-07-03
06975339628536Single-Use Biopsy ForcepsBF-F-1.8×600-O2026-07-03
06975339628550Single-Use Grasping ForcepsGF-F-1.8×6002026-07-03
06975339628567Single-Use Grasping ForcepsGF-F-1.8×600-G2026-07-03
06975339628574Single-Use Grasping ForcepsGF-F-1.8×600-O2026-07-03
06975339628598Single-Use Biopsy ForcepsBF-S-1.6×380-G2026-07-03
06975339628604Single-Use Biopsy ForcepsBF-S-1.6×380-O2026-07-03
06975339628611Single-Use Alligator GrasperGF-S-1.6×380-G2026-07-03
06975339628635Single-use Endoscopic ScissorsPS-S-1.6×380-G2026-07-03
06975339628642Single-use Endoscopic ScissorsPS-S-1.6×380-O2026-07-03
06975339620318CoralView®U10-B2024-03-12
06975339620325CoralView®U10-BR2024-03-12
06975339620332CoralView®U202024-03-28
06975339620349CoralView®U20-B2024-03-28
06975339620356CoralView®U20-BR2024-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975339628406Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.HFB2026-07-03
06975339628413Single-Use Alligator GrasperMacroLux Medical Technology Co., Ltd.HFB2026-07-03
06975339628598Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.HFB2026-07-03
06975339628604Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.HFB2026-07-03
06975339628611Single-Use Alligator GrasperMacroLux Medical Technology Co., Ltd.HFB2026-07-03
06950190431006NAZhuji Pengtian Medical Instrument Co.,Ltd.HFB2026-03-31
00190776418014MillenniumAvalign Technologies, Inc.HFB2026-03-23
00850033976366HERizon Disposable Endoscopic Forceps – Alligator XLMinerva Surgical, Inc.HFB2026-02-12
00840306837302Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HFB2025-10-24
00840306837319Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HFB2025-10-24
04059453057327Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHFB2025-08-28
06973672291066JiyuanJiangsu Jiyuan Medical Technology Co .,Ltd.HFB2025-08-12
16973672291063JiyuanJiangsu Jiyuan Medical Technology Co .,Ltd.HFB2025-08-12
00194613029302MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613033590MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613060480MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613106423MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613108076MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613117641MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613117726MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
06973672291059JiyuanJiangsu Jiyuan Medical Technology Co .,Ltd.HFB2025-07-31
16973672291056JiyuanJiangsu Jiyuan Medical Technology Co .,Ltd.HFB2025-07-31
00190776406974MillenniumAvalign Technologies, Inc.HFB2025-07-25
05010058082595InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-06-25
05010058182592InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-06-25
05010058080478InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-06-23
05010058180475InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-06-23
00190776401771MillenniumAvalign Technologies, Inc.HFB2025-06-13
00198506083013ELMED INCORPORATEDELMED INCORPORATEDHFB2025-05-22
05010058082588InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-05-21