FDA.reportPublic FDA data

TissuePro™ Distal Sleeve, MN Retractor Single-Use

Primary DI
00860013984632
Brand
TissuePro™ Distal Sleeve, MN Retractor Single-Use
Company
Armor Dental Corp.
Model
83209-SPU
Published
2025-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EIFAccessories, Retractor, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013984632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013984632008600139846328600139846320860013984632

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held dental retractorA hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
035988858
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010019658MirroSoft™ TearDrop Mirror832002025-05-12
00860010019665MirroSoft™ No. 4 Mirror832102025-05-12
00860010019672MirroSoft™ No. 5 Mirror832022025-05-12
00860010019689MirroSoft™ No. 5 Double Mirror832032025-05-12
00860010019696MirroSoft™ Delta Mirror832042025-05-12
00860013984601TissuePro™ Distal Sleeve, MN Retractor83209-AC2025-05-12
00860013984618TissuePro™ Proximal Sleeve, MN Retractor832102025-05-12
00860013984625TissuePro™ Single Sleeve, MN Retractor832112025-05-12
00860009411906Tongue-Guide™ Infant Home609002023-07-13
00860009411913Scan-Mate® (Black)401002023-07-13
00860009411920Scan-Mate® (Blue) 401012023-07-13
00860009411937Comfort-Soft™ Small Mectron732062023-07-13
00860009411944Comfort-Soft™ Large Mectron732052023-07-13
00860009411951Tongue-Guide™ Standard Pro 602002023-07-13
00860009411968Comfort-Soft™ Large MouthWatch732052023-07-13
00860009411975Comfort-Soft™ Large Delta Dental732022023-07-13
00860009411999Mouth-Mate® 401022023-07-13
00860010019603Comfort-Soft™ Small 732012023-07-13
00860010019610Comfort-Soft™ Large732002023-07-13
00860010019627Tongue-Guide™ Infant Pro 608002023-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454000250COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000885COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000892COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000908COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000915COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000922COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000939COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000946COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000953COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000960COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002001COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002308COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002315COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002803COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002810COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002827COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002834COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002841COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454004876COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454005019COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454005026COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006085COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006214COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006221COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006245COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006252COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006429COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454011867COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454013489COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454013496COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21