FDA.reportPublic FDA data

OTELO INSTRUMENTATION

Primary DI
07640178971134
Brand
OTELO INSTRUMENTATION
Company
SpineArt SA
Model
OTO-IN AB 01-N
Catalog number
OTO-IN AB 01-N
Device description
Anterior Blade, Down-curved
Published
2018-07-27
Public version status
Update
Distribution status
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
07640178971134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640178971134076401789711347640178971134

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
00190776400620MillenniumAvalign Technologies, Inc.GAD2026-07-19
00190776400330MillenniumAvalign Technologies, Inc.GAD2026-07-17
00190776400361MillenniumAvalign Technologies, Inc.GAD2026-07-17
00190776400453MillenniumAvalign Technologies, Inc.GAD2026-07-17
00198506039072ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092152ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092190ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092206ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092213ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092220ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092237ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092244ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092251ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092268ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092275ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092282ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092299ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092305ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092312ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092329ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092336ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092626ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00810220800454Adler Instrument CompanyAdler, Inc.GAD2026-07-17
04058749048186NAFehling Instruments GmbH & Co. KGGAD2026-07-17
04058749049800NAFehling Instruments GmbH & Co. KGGAD2026-07-17
04058749078008NAFehling Instruments GmbH & Co. KGGAD2026-07-17
B382SD907808200Surgical DirectSurgical Direct, Inc.GAD2026-07-17
B382SD907808210Surgical DirectSurgical Direct, Inc.GAD2026-07-17
B382SD9079001010Surgical DirectSurgical Direct, Inc.GAD2026-07-17
B382SD97247105T0Surgical DirectSurgical Direct, Inc.GAD2026-07-17