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Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 20-10686SModel Internal Nasal SplintRef 20-10680Ref 20-30685Ref 20-30041R-SRef 20-10685BRef 20-10682RRef 20-10680S

by Invotec International, Inc.

Identity

Trade Name
Custom-Cut Internal Nasal Splint EUDAMED
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing FDA UDI
Custom Cut Internal Nasal Splint FDA UDI
Generic Name
Intranasal splint, non-biodegradable FDA UDI
Device Name
Internal Nasal Splint EUDAMED
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing, 2.2 X 3.0 X 0.060" Singles FDA UDI
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing, Reinforced 1.0" X 1.0" X 0.040" FDA UDI
Custom Cut Internal Nasal Splint, 38 X 64 X 0.50mm FDA UDI
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing, 2.2 X 3.0 X 0.040", Singles FDA UDI
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing, Blue 1.5 X 2.0 X 0.005" FDA UDI
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing, Reinforced 2.2 X 3.0 X 0.020" FDA UDI
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing, 2.2 X 3.0 X 0.040" FDA UDI
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing, 2.2 X 3.0 X 0.060" FDA UDI
Model / Reference
20-10686S EUDAMEDFDA UDI
20-10680S EUDAMEDFDA UDI
20-10685B EUDAMEDFDA UDI
20-10682R EUDAMEDFDA UDI
20-10680 EUDAMEDFDA UDI
Internal Nasal Splint EUDAMED
20-30685 EUDAMED
20-30041R-S EUDAMED
20-30041RS FDA UDI
20-10675 FDA UDI
20-10686 FDA UDI
Description
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing, 2.2 X 3.0 X 0.060" Singles FDA UDI
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing, Reinforced 1.0" X 1.0" X 0.040" FDA UDI
Custom Cut Internal Nasal Splint, 38 X 64 X 0.50mm FDA UDI
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing, 2.2 X 3.0 X 0.040", Singles FDA UDI
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing, Blue 1.5 X 2.0 X 0.005" FDA UDI
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing, Reinforced 2.2 X 3.0 X 0.020" FDA UDI
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing, 2.2 X 3.0 X 0.040" FDA UDI
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing, 2.2 X 3.0 X 0.060" FDA UDI

Identifiers

Catalog Number
20-10686S FDA UDI
20-30041RS FDA UDI
20-10675 FDA UDI
20-10680S FDA UDI
20-10685B FDA UDI
20-10682R FDA UDI
20-10680 FDA UDI
20-10686 FDA UDI
Primary DI / UDI-DI
00818501022687 EUDAMEDFDA UDI
00818501021048 EUDAMEDFDA UDI
00818501020911 EUDAMEDFDA UDI
00818501022984 EUDAMEDFDA UDI
00818501021031 EUDAMEDFDA UDI
00818501021086 EUDAMEDFDA UDI
00818501023141 EUDAMED
00818501021093 FDA UDI
00818501021017 FDA UDI
Basic UDI-DI
081850102IntNasalSplintHX EUDAMED
FDA Product Code
LYA FDA UDI
EMDN Code
Q0399 ENT DEVICES - OTHER EUDAMED
GMDN Term
Intranasal splint, non-biodegradable FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
874.4780 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Intranasal splint, non-biodegradable

Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing by Invotec International, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Intranasal splint, non-biodegradable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Invotec International, Inc.

Sources (15)

  • FDA UDI 1e1a15c2-e91a-4c03-9911-c23f0d2103f0 34 fields · synced Aug 1, 2026
  • FDA UDI 0f6fbe7e-3285-4b54-ba88-7006a3931b79 34 fields · synced May 25, 2026
  • FDA UDI e608a362-583c-4807-bf64-198396e871bb 34 fields · synced May 27, 2026
  • FDA UDI e462cc6e-9bb1-4f16-87c3-76362fb72fdc 34 fields · synced May 30, 2026
  • FDA UDI 06c6c21d-a684-4b6c-9e93-a78df220f3c2 34 fields · synced May 30, 2026
  • FDA UDI 8f081056-0731-494e-9775-b6a2247e4b6f 34 fields · synced May 30, 2026
  • FDA UDI 1962a336-2b9c-4da6-a3ef-879412d7266a 34 fields · synced May 30, 2026
  • FDA UDI 69e3ffc8-a1eb-4845-9add-6f7e6713527b 34 fields · synced May 30, 2026
  • EUDAMED 39fa7e0d-9dba-46f1-9a47-8dff67408972 61 fields · synced Jun 20, 2026
  • EUDAMED 6c26b2e9-413a-4b82-b4f7-77d74837acbc 61 fields · synced Jul 13, 2026
  • EUDAMED ae76f848-8aa7-4d5c-8574-3120e3b789cd 61 fields · synced Jul 13, 2026
  • EUDAMED 919e09f5-f360-49c3-9eb0-868b974bc583 61 fields · synced Jul 13, 2026
  • EUDAMED 335085d6-130a-42ee-a33e-6087503e4139 61 fields · synced Jul 13, 2026
  • EUDAMED 70ea1a57-d1b3-4b9c-b6bb-069e1834e8bf 61 fields · synced Jul 18, 2026
  • EUDAMED fee40c41-1197-4f30-9cf9-05c7816593ab 61 fields · synced Jul 28, 2026