FDA.reportPublic FDA data

Salvin Implant Retractor

Primary DI
00841336102804
Brand
Salvin Implant Retractor
Company
Salvin Dental Specialties, Inc.
Model
IMPLANT-RETRACT
Published
2023-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EIFAccessories, Retractor, Dental
EIGRetractor, All Types

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1
EIGRetractor, All TypesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841336102804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841336102804008413361028048413361028040841336102804

GMDN Terms#

Term, Definition table
TermDefinition
Dental cheek retractor, professional, reusableA hands-free, self-retaining frame intended to allow a dental professional to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure for easy access to the field of operation. It is designed to be placed in and around the lips/cheeks and may also be designed to displace the tongue. It is a synthetic polymer device which may include suction adaptors/tubing for saliva removal to maintain a dry field. It is not intended to be placed between the teeth (i.e., not a mouth gag). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
113344790
Device count
1
DM exempt
true
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
00841336112032SalvinORAMEM-PLUS-15x202024-05-31
00841336112049SalvinORAMEM-PLUS-20x302024-05-30
00841336112056SalvinORAMEM-PLUS-30x402024-05-30
00841336111929SALVINOSS-BSALVINOSS-B-0.52024-05-27
00841336111936SALVINOSS-BSALVINOSS-B-1.02024-05-27
00841336111943SALVINOSS-BSALVINOSS-B-2.02024-05-27
00841336111950SALVINOSS-BSALVINOSS-B-4.02024-05-27
00841336111998SALVINOSS-BSALVINOSS-B-SYR-0.252024-05-27
00841336112001SALVINOSS-BSALVINOSS-B-SYR-0.502024-05-27
00841336112018SALVINOSS-BSALVINOSS-B-SYR-1.002024-05-27
00841336101760Salvin Stainless Steel UNC ProbePROBE-UNC2023-08-21
00841336103146Replacement Mallet Cap (Set of 2)MALLET-CAP2023-08-18
00841336103054#5 Front Surface Cone Socket Mirror - Box of 12MIRR-5-CS2023-08-16
00841336102675Flexible Stainless Steel Surgical Ruler - 6" (15.25cm)SURGRULER2023-08-11
00841336101128Salvin Adson Tissue Forcep-Curved-Serrated 4 3/4"ADSON-SERR-CURV2023-08-10
00841336101135Salvin Adson Titanium Curved Tissue Forceps 12cmADSON-TI-CURVED2023-08-10
00841336101142Salvin Bayonet Elevator Offset "In" - SmallBAYONET-ELEV-22023-08-10
00841336101159Salvin Debakey Atraumatic Tissue Forcep StraightDEBAKEY-STRAIGHT2023-08-10
00841336101166Salvin DEF 23 German Stainless Steel Extraction ForcepDEF 232023-08-10
00841336101173Salvin Serrated Elevator - 3mmDEL-SERR-32023-08-10

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