FDA.reportPublic FDA data

Anodyne Surgical

Primary DI
00840516141978
Brand
Anodyne Surgical
Company
Psi/Eye-Ko, Inc.
Model
8001T
Device description
Lacrimal Intubation 7" Set W/ Bulbous Tip
Published
2023-12-21
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
OKSLacrimal Stents And Intubation Sets

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKSLacrimal Stents And Intubation SetsUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840516141978PackageGS110In Commercial Distribution
00840516141961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840516141978008405161419788405161419780840516141978
00840516141961008405161419618405161419610840516141961

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal intubation setA collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
1(800)428-5628info@anodynesurgical.com

Regulatory Flags#

DUNS number
063763833
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840516145884Anodyne SurgicalCB20112026-06-02
00840516145839Anodyne Surgical7007D2026-05-12
00840516145747Anodyne SurgicalRx404062026-04-17
00840516145761Anodyne SurgicalRx909052026-04-17
00840516145808Anodyne SurgicalCK20012026-04-17
00840516145815Anodyne SurgicalCK20022026-04-17
00840516142784Anodyne SurgicalAE03-2001-45062025-06-20
00840516142777Anodyne SurgicalAE03-2001-45062025-06-20
00840516142647Anodyne Surgical9903-8FSP2025-06-12
00840516142654Anodyne Surgical9903-8FSP2025-06-12
00840516109893Anodyne Surgical8000-262023-06-21
00840516113326Anodyne Surgical8000-262023-06-21
00840516117454Anodyne Surgical8000-262023-08-30
00840516127842Anodyne Surgical0002F2023-08-23
00840516127859Anodyne Surgical00072023-08-23
00840516127866Anodyne Surgical0018B2023-08-23
00840516127873Anodyne Surgical0020-212023-08-23
00840516127880Anodyne Surgical0020.22023-08-23
00840516127897Anodyne Surgical1000-4.12023-08-23
00840516127903Anodyne Surgical1000-4.22023-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
13700773729651STOPLOSS® JONES TUBE 3,5 X 9 MM FCI S A S FCI 20 22OKS2026-04-20
13700773729668STOPLOSS® JONES TUBE 3,5 X 10 MM FCI S A S FCI 20 22OKS2026-04-20
13700773729675STOPLOSS® JONES TUBE 3,5 X 11 MM FCI S A S FCI 20 22OKS2026-04-20
13700773729682STOPLOSS® JONES TUBE 3,5 X 12 MM FCI S A S FCI 20 22OKS2026-04-20
13700773729699STOPLOSS® JONES TUBE 3,5 X 13 MM FCI S A S FCI 20 22OKS2026-04-20
13700773730817STOPLOSS® JONES TUBE INTRODUCER SET FCI S A S FCI 20 22OKS2026-04-20
13700773731920STOPLOSS® JONES TUBE 3,5 X 14 MM FCI S A S FCI 20 22OKS2026-04-20
13700773731937STOPLOSS® JONES TUBE 3,5 X 15 MM FCI S A S FCI 20 22OKS2026-04-20
13700773731968STOPLOSS® JONES TUBE 3,5 X 16 MM FCI S A S FCI 20 22OKS2026-04-20
13700773731975STOPLOSS® JONES TUBE 3,5 X 17 MM FCI S A S FCI 20 22OKS2026-04-20
13700773731982STOPLOSS® JONES TUBE 3,5 X 18 MM FCI S A S FCI 20 22OKS2026-04-20
13700773731999STOPLOSS® JONES TUBE 3,5 X 19 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732002STOPLOSS® JONES TUBE 3,5 X 20 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732019STOPLOSS® JONES TUBE 3,5 X 21 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732026STOPLOSS® JONES TUBE 3,5 X 22 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732033STOPLOSS® JONES TUBE 4 X 9 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732040STOPLOSS® JONES TUBE 4 X 10 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732057STOPLOSS® JONES TUBE 4 X 11 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732064STOPLOSS® JONES TUBE 4 X 12 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732071STOPLOSS® JONES TUBE 4 X 13 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732088STOPLOSS® JONES TUBE 4 X 14 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732095STOPLOSS® JONES TUBE 4 X 15 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732101STOPLOSS® JONES TUBE 4 X 16 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732118STOPLOSS® JONES TUBE 4 X 17 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732125STOPLOSS® JONES TUBE 4 X 18 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732132STOPLOSS® JONES TUBE 4 X 19 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732149STOPLOSS® JONES TUBE 4 X 20 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732156STOPLOSS® JONES TUBE 4 X 21 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732163STOPLOSS® JONES TUBE 4 X 22 MM FCI S A S FCI 20 22OKS2026-04-20
13700773735072STOPLOSS® JONES TUBE REMOVAL TOOL FCI S A S FCI 20 22OKS2026-04-20