FDA.reportPublic FDA data

Michel Wound Clips

Primary DI
00192896120228
Brand
Michel Wound Clips
Company
SONTEC INSTRUMENTS, INC.
Model
1100-780
Catalog number
1100-780
Device description
Michel Wound Clips Stainless Steel (100 Per Box)
Published
2024-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDTSTAPLE, REMOVABLE (SKIN)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDTStaple, Removable (Skin)General, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896120228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896120228001928961202281928961202280192896120228

GMDN Terms#

Term, Definition table
TermDefinition
General skin wound clipA metallic surgical instrument intended to be used to approximate the edges of any skin wound (non-dedicated) to facilitate wound healing and/or for the placement of sutures. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length22Millimeter

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

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Primary DI, Brand, Company table
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