FDA.report

ASSI

Primary DI
00841645111115
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.CAF3
Device description
Clamp Applying Fcps., Flat Hdl. 15cm W/Out Lock, Angled
Published
2023-06-29
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
HDXDilator, Vaginal

Product Code Classifications

CodeDeviceSpecialtyClass
HDXDilator, VaginalObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841645111115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645111115008416451111158416451111150841645111115

GMDN Terms

TermDefinition
Dressing/utility forceps, tweezers-like, reusableA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is made of metal and/or plastic materials and is available in various sizes. 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

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00810142352307Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-30
00810142352215Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352222Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352239Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352246Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352260Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352277Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352284Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352291Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352314Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-12
00810142352253Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-08
00860012225002Hope&Her Vaginal DilatorsLUJENA, INC.HDX2024-11-15
B8034701660ORTHOMEDORTHO-MED, INC.HDX2024-05-17
04719894432236Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-04-08
04719894432243Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-04-08
04719894432250Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-04-08
04719894432267Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-04-08
04719894432274Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-04-08
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04719894432304Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-04-08
04719894432205Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-03-29
04719894432212Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-03-29
04719894432229Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-03-29
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