FDA.report

ONE® Oasis Silk bottle

Primary DI
00726893210158
Brand
ONE® Oasis Silk bottle
Company
GLOBAL PROTECTION CORP.
Model
11L401C
Device description
ONE® Oasis Silk 2oz Bottle
Published
2023-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NUCLubricant, Personal

Product Code Classifications

CodeDeviceSpecialtyClass
NUCLubricant, PersonalObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20726893210152PackageGS196In Commercial Distribution
00726893210158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2072689321015220726893210152
00726893210158007268932101587268932101580726893210158

GMDN Terms

TermDefinition
Sexual lubricantA substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature in a dark, dry place. Avoid excessive heat.

Sterilization Methods

Method

Regulatory Flags

DUNS number
364614362
Device count
1
DM exempt
false
Premarket exempt
false
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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