FDA.report

Adler Instrument Company

Primary DI
00810123201853
Brand
Adler Instrument Company
Company
Adler, Inc.
Model
ADCV5025
Device description
Fogarty Hydragrip Clamps
Published
2023-03-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DXCClamp, Vascular

Product Code Classifications

CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810123201853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810123201853008101232018538101232018530810123201853

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

Contacts

PhoneEmail
8772416747orders@theadlerinstruments.com

Regulatory Flags

DUNS number
830141235
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
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

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