FDA.report

ASSI

Primary DI
00841645135609
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.SU33826
Device description
Antrum Punch Fcps. Adult Pattern, Left Cut, Jaw Size: 1.5 X 1.0 100mm Wkg. Lgth.
Published
2020-07-10
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
LRYPunch, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
LRYPunch, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841645135609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645135609008416451356098416451356090841645135609

GMDN Terms

TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
055870299
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
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
00841645143215ASSIASSI.BPNS243252023-08-18
00841645143222ASSIASSI.BPNS153392023-08-18
00841645142843ASSIASSI.SU632262023-08-11
00841645104988ASSIASSI.ACC1VB2023-08-11
00841645105091ASSIASSI.R1A2023-08-11
00841645105107ASSIASSI.ACC11AB2023-08-11
00841645105176ASSIASSI.DC1VB2023-08-11
00841645107385ASSIASSI.BS18822023-08-11
00841645108412ASSIASSI.005822023-08-11
00841645108474ASSIASSI.158842023-08-11
00841645108498ASSIASSI.16252023-08-11
00841645108542ASSIASSI.16632023-08-11
00841645108573ASSIASSI.16672023-08-11
00841645108634ASSIASSI.17002023-08-11
00841645108665ASSIASSI.17342023-08-11
00841645108696ASSIASSI.17402023-08-11
00841645108733ASSIASSI.17682023-08-11
00841645108771ASSIASSI.18002023-08-11
00841645108795ASSIASSI.18022023-08-11
00841645108856ASSIASSI.18322023-08-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08681506800282SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2026-02-17
08681506800299SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2026-02-17
08681506800268SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-25
08681506800275SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-25
08681506800060SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800077SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800091SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800107SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800114SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800121SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800138SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800145SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800152SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800169SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800176SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800183SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800190SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800206SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800213SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800220SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800237SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800244SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800251SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800015SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
08681506800022SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
08681506800039SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
08681506800046SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
08681506800053SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
08681506800084SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
04262494460029N/ADoppkon GmbH & Co. KGLRY2025-12-04