Remplir™

Primary DI
09358206000043
Brand
Remplir™
Company
ORTHOCELL LIMITED
Model
ON-152
Published
2025-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JXICuff, Nerve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXICuff, NerveNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243889000Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)Orthocell, Ltd.2025-04-02JXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19358206000040PackageGS110In Commercial Distribution
09358206000043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1935820600004019358206000040
09358206000043093582060000439358206000043

GMDN Terms#

Term, Definition table
TermDefinition
Nerve guide, animal-derivedAn implantable tubular device made exclusively of animal-derived bioabsorbable material(s) [e.g., porcine-derived collagen matrix, chitosan] intended to be used to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve stumps. The device is typically used during hand surgery and/or nerve reconstruction. It is intended to be chemically degraded and typically absorbed via natural body processes. It is also known as a nerve sheath, nerve cuff, nerve protector, nerve conduit, or a nerve wrap.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Millimeter
Width15Millimeter

Regulatory Flags#

DUNS number
754598449
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09358206000074Remplir™ON-4052025-04-07
19358206000040Remplir™ON-1522025-04-07
09358206000050Remplir™ON-2032025-04-07
09358206000067Remplir™ON-3042025-04-07
19358206000071Remplir™ON-4052025-04-07
09358206000081perFORM™perf15202023-04-18
09358206000098perFORM™perf20302023-04-18
09358206000104perFORM™perf30402023-04-18
09358206000005Striate+™OCG-1522021-04-27
09358206000012Striate+™OCG-2032021-04-27
09358206000029Striate+™OCG-3042021-04-27
09358206000036Striate+™OCG-4052021-04-27

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