FDA.reportPublic FDA data

Padgett Replacement Dermatome Blades Sterile

Primary DI
98500107790286
Brand
Padgett Replacement Dermatome Blades Sterile
Company
Robbins Instruments Inc
Model
9.1999
Catalog number
9.1999
Device description
Padgett Replacement Dermatome Blades Sterile 100mm
Published
2019-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
98500107790286PrimaryGS10
18500107790280Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
9850010779028698500107790286
1850010779028018500107790280

GMDN Terms#

Term, Definition table
TermDefinition
Dermatome blade, single-useA surgical cutting device that is designed to be mounted into a dermatome and used to provide the cutting edge for the harvesting of skin grafts or excision of small skin lesions. It is available in various sizes. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(973)635-8972info@robbinsinstruments.com

Regulatory Flags#

DUNS number
002182269
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
98500107790019Robbins True-Cut Disposable Biopsy PunchesRBP-03RBP-032019-10-25
98500107790026Robbins True-Cut Disposable Biopsy PunchesRBP-05RBP-052019-10-25
98500107790033Robbins True-Cut Disposable Biopsy PunchesRBP-075RBP-0752019-10-25
98500107790040Robbins True-Cut Disposable Biopsy PunchesRBP-075PRBP-075P2019-10-25
98500107790057Robbins True-Cut Disposable Biopsy PunchesRBP-10RBP-102019-10-25
98500107790064Robbins True-Cut Disposable Biopsy PunchesRBP-10PRBP-10P2019-10-25
98500107790071Robbins True-Cut Disposable Biopsy PunchesRBP-12RBP-122019-10-25
98500107790088Robbins True-Cut Disposable Biopsy PunchesRBP-15RBP-152019-10-25
98500107790095Robbins True-Cut Disposable Biopsy PunchesRBP-15PRBP-15P2019-10-25
98500107790101Robbins True-Cut Disposable Biopsy PunchesRBP-20RBP-202019-10-25
98500107790118Robbins True-Cut Disposable Biopsy PunchesRBP-20PRBP-20P2019-10-25
98500107790125Robbins True-Cut Disposable Biopsy PunchesRBP-25RBP-252019-10-25
98500107790132Robbins True-Cut Disposable Biopsy PunchesRBP-30RBP-302019-10-25
98500107790149Robbins True-Cut Disposable Biopsy PunchesRBP-30PRBP-30P2019-10-25
98500107790156Robbins True-Cut Disposable Biopsy PunchesRBP-35RBP-352019-10-25
98500107790163Robbins True-Cut Disposable Biopsy PunchesRBP-40RBP-402019-10-25
98500107790170Robbins True-Cut Disposable Biopsy PunchesRBP-50RBP-502019-10-25
98500107790187Robbins True-Cut Disposable Biopsy PunchesRBP-60RBP-602019-10-25
98500107790194Robbins True-Cut Disposable Biopsy PunchesRBP-80RBP-802019-10-25
98500107790200Robbins True-Cut Disposable Biopsy PunchesRBP-100RBP-1002019-10-25

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