FDA.reportPublic FDA data

SPATULA

Primary DI
00888118102522
Brand
SPATULA
Company
KLS-Martin L.P.
Model
24-231-30-01
Device description
LUNG, ALLISON
Published
2018-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAFSpatula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118102522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118102522008881181025228881181025220888118102522

GMDN Terms#

Term, Definition table
TermDefinition
Lung spatulaA hand-held manual surgical instrument designed to manipulate the pulmonary tissue/surfaces of the lungs during a surgical intervention in the thorax. It typically consists of a large flat blunt blade (no sharp edges) at the distal end and a strong handle at the proximal end. It is usually made of stainless steel and is available with a variety of blade designs, e.g., curved and flat with a protected rounded end, a wire basket structure of interconnected round wires, or broad and flat with fenestrations. The blade and handle can be designed to be at various ergonomic angles to each other. This instrument is sometimes referred to as a lung retractor. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118108357DISTRACTION, INTERNAL, STERILE51-556-20-812018-09-26
00888118108364DISTRACTION, INTERNAL, STERILE51-557-20-812018-09-26
00888118147226LEVEL ONE EXTREMITY26-950-64-042026-07-21
00888118147233LEVEL ONE EXTREMITY26-950-65-042026-07-21
00888118147240LEVEL ONE EXTREMITY26-950-66-042026-07-21
00888118147257LEVEL ONE EXTREMITY26-950-67-042026-07-21
00888118147264LEVEL ONE EXTREMITY26-950-68-042026-07-21
00888118147271LEVEL ONE EXTREMITY26-950-69-042026-07-21
00888118147714LEVEL ONE EXTREMITY26-950-58-042026-07-21
00888118147721LEVEL ONE EXTREMITY26-950-59-042026-07-21
00888118147738LEVEL ONE EXTREMITY26-950-62-042026-07-21
00888118147745LEVEL ONE EXTREMITY26-950-63-042026-07-21
00888118154620LEVEL ONE CMF25-315-92-912026-07-21
00888118154637LEVEL ONE CMF50-743-06-092026-07-21
00888118154644LEVEL ONE, STERILE25-433-97-712026-07-21
00888118154651LEVEL ONE, STERILE25-438-97-712026-07-21
00888118154668LEVEL ONE, STERILE25-439-91-712026-07-21
00888118154675LEVEL ONE, STERILE25-486-97-712026-07-21
00888118154682LEVEL ONE, STERILE25-487-97-712026-07-21
00888118154699LEVEL ONE, STERILE50-817-15-712026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850088713770PRINCETONPrinceton Medical Group, Inc.GAF2026-09-22
04054462902675evonosevonos GmbH & Co. KGGAF2026-08-21
04054462902682evonosevonos GmbH & Co. KGGAF2026-08-21
04054462902750evonosevonos GmbH & Co. KGGAF2026-08-21
04054462917495evonosevonos GmbH & Co. KGGAF2026-08-19
04054462901548evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902699evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902705evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902712evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902729evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902736evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902743evonosevonos GmbH & Co. KGGAF2026-08-18
B382SD571001EV0Surgical DirectSurgical Direct, Inc.GAF2026-08-03
B382SD571002EV0Surgical DirectSurgical Direct, Inc.GAF2026-08-03
B382SD571004EV0Surgical DirectSurgical Direct, Inc.GAF2026-08-03
08961104622548Spatula 6mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
08961104622555Spatula 8.0 mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
08961104622562Spatula 10 mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
00840343727352GEN2SURGIX MEDICAL LLCGAF2026-04-16
10889950147624Hu-FriedyHU-FRIEDY MFG. CO., LLCGAF2026-02-24
00840018668164Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-02-10
00840018662810Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-01-29
00840018662827Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-01-29
00810158218420PRINCETONPrinceton Medical Group, Inc.GAF2026-01-07
B382SD9150391000Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150391050Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150391060Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150471120Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD915095250Surgical DirectSurgical Direct, Inc.GAF2025-12-29
08800075627766OSUNG MNDOSUNG MND Co., Ltd.GAF2025-11-03