Juveena Hydrogel System

Primary DI
00860010540961
Brand
Juveena Hydrogel System
Company
Rejoni, Inc.
Model
JA-2101
Published
2026-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MCNBarrier, Absorbable, Adhesion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCNBarrier, Absorbable, AdhesionUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P250051000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P250051000Juveena Hydrogel SystemRejoni, Inc.2026-09-28MCN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010540961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010540961008600105409618600105409610860010540961

GMDN Terms#

Term, Definition table
TermDefinition
Surgical anti-adhesion material, nonimplantableA material intended to be placed in the body short term (<= 30 days) to prevent the abnormal fibrous union (adhesion) between one body part/tissue to another, or between one body part/tissue and a dressing, following a surgical procedure. It is made of a single or composite polymer (e.g., hydrogel, silicone) in the form of a barrier membrane or fluid dressing, and may be cut to a desired size/shape. This is a single-use device.

Regulatory Flags#

DUNS number
118420242
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010540930Rejoni Ribbed CatheterRC-2015RC-20152025-02-18
00860010540909Rejoni Intrauterine CatheterCA-2015CA-20152023-07-14
10860010540937Rejoni Ribbed CatheterRC-2015RC-20152025-02-18

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Primary DI, Brand, Company table
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10705031005396GYNECARE INTERCEEDEthicon SàrlMCN2014-09-20
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20705031147840GYNECARE INTERCEEDETHICON, LLCMCN2014-09-20
20705031005393GYNECARE INTERCEEDETHICON, LLCMCN2014-09-20