FDA.report

Sticky Tim

Primary DI
E2212248
Brand
Sticky Tim
Company
VOCO GmbH
Model
2248
Catalog number
2248
Published
2025-01-22
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

Related Records

Product Codes

CodeName
FRLFiber, Medical, Absorbent

Product Code Classifications

CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E22122481PrimaryHIBCC0
E2212248Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental material application tool, single-useA hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
999-999-9999xxx@xx.xx

Regulatory Flags

DUNS number
316699578
Device count
70
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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E22162861GrandioSO 4U628662862025-06-02
E22162871GrandioSO 4U628762872025-06-02
E22162881GrandioSO 4U628862882025-06-02
E22162891GrandioSO 4U628962892025-06-02
E22162901GrandioSO 4U629062902025-06-02
E22162951GrandioSO 4U629562952025-06-02
E22162961GrandioSO 4U629662962025-06-02
E22162971GrandioSO 4U629762972025-06-02
E22162981GrandioSO 4U629862982025-06-02
E22162991GrandioSO 4U629962992025-06-02

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