FDA.reportPublic FDA data

SANDEL

Primary DI
35414566810014
Brand
SANDEL
Company
Ansell Sandel Medical Solutions LLC
Model
2200
Catalog number
2200
Device description
SANDEL SAFETY SCALPEL HANDLE, CAB, 2200
Published
2022-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35414566810014PackageGS14In Commercial Distribution
25414566810017PrimaryGS10
00071483005172Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3541456681001435414566810014
2541456681001725414566810017
00071483005172000714830051720714830051720071483005172

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
775-746-6600jacob.ramirez@ansell.com

Regulatory Flags#

DUNS number
107961166
Device count
12
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
25414566810031SANDEL220422042022-03-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661219436522LANDANGERLANDANGERMDM2026-07-08
03661219436584LANDANGERLANDANGERMDM2026-07-08
03661219436706LANDANGERLANDANGERMDM2026-07-08
04054462915583evonosevonos GmbH & Co. KGMDM2026-06-25
00198506091612ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-24
00198506091629ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-24
00810158211179PRINCETONPrinceton Medical Group, Inc.MDM2026-06-23
00198506091353ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091384ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091407ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091209ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-03
00810130456406Medco ManufacturingMedco Manufacturing LLCMDM2026-06-02
00846338007126Endiscope and accessoriesELLIQUENCE, LLCMDM2026-06-02
00846338005429DilatorELLIQUENCE, LLCMDM2026-06-01
06932503510219Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29
06932503510226Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29
B356KE392100American MedicalsAmerican MedicalsMDM2026-05-29
B356KE396100American MedicalsAmerican MedicalsMDM2026-05-29
08800042700102Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700140Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700256Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700270Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700287Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700300Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700317Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700324Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700386Artisential Needle HolderLIVSMEDMDM2026-04-29