FDA.reportPublic FDA data

SANDEL

Primary DI
25414566810031
Brand
SANDEL
Company
Ansell Sandel Medical Solutions LLC
Model
2204
Catalog number
2204
Device description
SANDEL SAFETY SCALPEL HANDLE, #4 CAB
Published
2022-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDZHandle, Scalpel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35414566810038PackageGS14In Commercial Distribution
25414566810031PrimaryGS10
00071483005356Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3541456681003835414566810038
2541456681003125414566810031
00071483005356000714830053560714830053560071483005356

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel handle, single-useA sterile device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
775-746-6600jacob.ramirez@ansell.com
775-470-7106don.cronk@ansell.com

Regulatory Flags#

DUNS number
107961166
Device count
12
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
25414566810147SANDEL114511452022-03-28
25414566810185SANDEL1145-NS1145-NS2022-03-25
25414566810208SANDEL1147-NS1147-NS2022-03-25
25414566810215SANDEL114711472022-03-25
25414566810048SANDEL2210-N2210-N2022-03-28
25414566810062SANDEL2211-N2211-N2022-03-28
25414566810086SANDEL2215-N2215-N2022-03-28
25414566810109SANDEL2220-N2220-N2022-03-28
25414566810116SANDEL2230-N2230-N2022-03-28
25414566810123SANDEL2231-N2231-N2022-03-28
25414566810130SANDEL2235-N2235-N2022-03-28
25414566810253SANDEL2200-LNS2200-LNS2022-03-28
25414566810260SANDEL2204-NS2204-NS2022-03-28
25414566810277SANDEL2210-NNS2210-NNS2022-03-28
25414566810284SANDEL2211-NNS2211-NNS2022-03-28
25414566810291SANDEL2215-NNS2215-NNS2022-03-28
25414566810307SANDEL2220-NNS2220-NNS2022-03-28
25414566810314SANDEL2230-NNS2230-NNS2022-03-28
35414566810038SANDEL220422042022-03-28
35414566810045SANDEL2210-N2210-N2022-03-28

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Primary DI, Brand, Company table
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00810055256112Surgical DesignSurgical Design, Inc.GDZ2026-06-26
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00810055256181Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256198Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256204Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810189455139Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00190776421847MillenniumAvalign Technologies, Inc.GDZ2026-06-25
00810055257348Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257355Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257362Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257379Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257386Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257850Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00190776421533MillenniumAvalign Technologies, Inc.GDZ2026-05-05
00190776419769MillenniumAvalign Technologies, Inc.GDZ2026-04-15
00190776419776MillenniumAvalign Technologies, Inc.GDZ2026-04-15
00190776419783MillenniumAvalign Technologies, Inc.GDZ2026-04-15