FDA.report

Beesure

Primary DI
00817508020122
Brand
Beesure
Company
ASCEND EAGLE INCORPORATED
Model
BE2200G
Device description
Face Mask with Peppermint Scent Green - Inner Pack
Published
2021-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications

CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20817508020126PackageGS18In Commercial Distribution
10817508020129PrimaryGS10
00817508020122Unit of UseGS10

GMDN Terms

TermDefinition
Neurofibromatosis type 1 IVD, controlA material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the inherited genetic disorder neurofibromatosis type 1 (von Recklinghausen disease or peripheral neurofibromatosis), an autosomal dominant disorder associated with mutation in the neurofibromin-1 (NF1) gene.

Sterilization Methods

Method

Contacts

PhoneEmail
7075536190jordan.lim@pro2s.com

Regulatory Flags

DUNS number
167102750
Device count
50
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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20817508023868CranberryCR39092025-09-02
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20817508020218CranberryCR35762025-05-08
20817508020324CranberryCR35772025-05-08
20817508020379CranberryCR35782025-05-08
20817508021710CranberryCR35792025-05-08
20817508023004ASAP205712022-07-07
20817508023028ASAP205722022-07-07
20817508023035ASAP205732022-07-07
20817508023059ASAP205742022-07-07
20817508023066ASAP205752022-07-07
20817508023226ASAP207112022-07-07
20817508023233ASAP207122022-07-07
20817508023240ASAP207132022-07-07
20817508023257ASAP207142022-07-07
20817508023264ASAP207152022-07-07

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08057147052111MDU7023S UNIVET SRLLYU2026-03-02
G1493806305TBS DentalACME ENTERPRISE.LYU2026-03-02
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