FDA.reportPublic FDA data

Umbrella Cheek Retractor

Primary DI
00883205033215
Brand
Umbrella Cheek Retractor
Company
ULTRADENT PRODUCTS, INC.
Model
5258
Catalog number
5258
Device description
Umbrella Cheek Retractor Large 40pk (Clear)
Published
2022-03-29
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIGRETRACTOR, ALL TYPES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIGRetractor, All TypesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883205033215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205033215008832050332158832050332150883205033215

GMDN Terms#

Term, Definition table
TermDefinition
Mouth gag, adjustable, reusableA mechanical device with adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral/dental surgical intervention. Also known as a jaw spreader, it is available in various designs having support structures that force and/or hold the jaws apart; e.g., it may be designed with flat, pivoted blades that angle outward when adjusted; or it may have two parallel plates that move apart with adjustments to a centre screw; or it may have a scissors-like design with pivoted, self-retaining, notched blades at the distal end. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(801)572-4200customerservice@ultradent.com

Regulatory Flags#

DUNS number
013369913
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Primary DI, Brand, Model table
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00883205044075Enamelast690769072026-02-11
00883205044082Enamelast691369132026-02-11
00883205044099Enamelast690869082026-02-11
00883205044105Enamelast690969092026-02-11
00883205044112Enamelast691069102026-02-11
00883205044129Enamelast691169112026-02-11
00883205044136Enamelast691269122026-02-11
00883205044983Porcelain Repair110811082026-01-30
00883205044372Valo X6496-DU6496-DU2025-12-04
00883205044389Valo X6497-DU6497-DU2025-12-04
00883205044396Valo X6498-DU6498-DU2025-12-04
00883205044402Valo X6499-DU6499-DU2025-12-04
00883205044419Valo X6519-DU6519-DU2025-12-04
00883205044426Valo X6538-DU6538-DU2025-12-04
00883205044143Enamelast689568952025-11-14
00883205044150Enamelast689668962025-11-14
00883205044167Enamelast689768972025-11-14
00883205044174Enamelast689868982025-11-14

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G149TBSB7990TBS BASICSACME ENTERPRISE.EIG2026-05-22
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B382SD915118290Surgical DirectSurgical Direct, Inc.EIG2026-02-16
B382SD915118300Surgical DirectSurgical Direct, Inc.EIG2026-02-16
04059453109095Hermann Medizintechnik GmbHHermann Medizintechnik GmbHEIG2026-02-13
B382SD5750050Surgical DirectSurgical Direct, Inc.EIG2026-02-10
B382SD9177181010Surgical DirectSurgical Direct, Inc.EIG2026-02-10
B382SD921052010Surgical DirectSurgical Direct, Inc.EIG2026-02-10
00888118150608RETRACTORKLS-Martin L.P.EIG2025-12-23
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