FDA.reportPublic FDA data

OTELO INSTRUMENTATION

Primary DI
07640151092986
Brand
OTELO INSTRUMENTATION
Company
SpineArt SA
Model
OTO-IN AB 02-N
Catalog number
OTO-IN AB 02-N
Device description
Anterior Blade, Up
Published
2018-07-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151104000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151104000OTELO LLSpineart2016-01-06GAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640151092986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640151092986076401510929867640151092986

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system, reusableA frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
483016148
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640221373021PERLA NAVNAV-IN 11 50-NNAV-IN 11 50-N2026-05-07
07640221373038PERLA ® TLHAN-FI BA 50-N2026-05-07
07640221373045PERLA ® TLTLF-IN 01 60-N2026-05-07
07640221373052PERLA NAVNAV-IN 43 30-NNAV-IN 43 30-N2026-05-07
07640221373069PERLA NAVNAV-IN 43 60-NNAV-IN 43 60-N2026-05-07
07640221373076PERLA ® TLTLF-IN 03 70-N2026-05-07
07640221373083PERLA ® TLTLF-IN 12 00-N2026-05-07
07640221373090PERLA ® TLTLF-IN 04 70-N2026-05-07
07640221373113PERLA NAVNAV-IN 41 75-NNAV-IN 41 75-N2026-05-07
07640221373120PERLA NAVNAV-IN 41 80-NNAV-IN 41 80-N2026-05-07
07640221373137PERLA NAVNAV-IN 41 85-NNAV-IN 41 85-N2026-05-07
07640221373144PERLA NAVNAV-IN 41 90-NNAV-IN 41 90-N2026-05-07
07640221373151PERLA NAVNAV-IN 41 95-NNAV-IN 41 95-N2026-05-07
07640221373168PERLA NAVNAV-IN 41 00-NNAV-IN 41 00-N2026-05-07
07640221373175PERLA NAVNAV-IN 41 05-NNAV-IN 41 05-N2026-05-07
07640221373182PERLA NAVNAV-IN 41 10-NNAV-IN 41 10-N2026-05-07
07640221373199PERLA NAVNAV-IN 41 15-NNAV-IN 41 15-N2026-05-07
07640221373205PERLA NAVNAV-IN 41 20-NNAV-IN 41 20-N2026-05-07
07640221373212PERLA NAVNAV-IN 41 25-NNAV-IN 41 25-N2026-05-07
07640221373229PERLA NAVNAV-IN 42 70-NNAV-IN 42 70-N2026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091926ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-22
00198506092015ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-22
00198506093685ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-22
00841731153104ARTEMIS FUZEVILEX LLCGAD2026-07-22
00841731153111ARTEMIS FUZEVILEX LLCGAD2026-07-22
B8038600980ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8038600990ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803860120L0ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8038601250ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039018420ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039018430ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039018840ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039030020ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803903220010ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803903220020ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039401000ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601360ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601370ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601390ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601400ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803NL97010ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803NL9701H0ORTHOMEDORTHO-MED, INC.GAD2026-07-22
00190776402174MillenniumAvalign Technologies, Inc.GAD2026-07-21
00190776403317MillenniumAvalign Technologies, Inc.GAD2026-07-21
00190776403324MillenniumAvalign Technologies, Inc.GAD2026-07-21
00190776403362MillenniumAvalign Technologies, Inc.GAD2026-07-21
00840183532185BR Surgical, LLCBR Surgical, LLCGAD2026-07-21
00840183532192BR Surgical, LLCBR Surgical, LLCGAD2026-07-21
00840183532222BR Surgical, LLCBR Surgical, LLCGAD2026-07-21
00840183532239BR Surgical, LLCBR Surgical, LLCGAD2026-07-21